Tuesday, November 11, 2014

New Implants For Surgery, Prosthetics And Orthotics Standards for the 3rd Quarter 2014

Document Center Inc. is pleased to announce that the following New Standards on Implants For Surgery, Prosthetics And Orthotics are now available:
  • ASTM F1223, 2014 Edition, Standard Test Method for Determination of Total Knee Replacement Constraint
  • ASTM F1926, 2014 Edition, Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
  • ASTM F2028, 2014 Edition, Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
  • ASTM F2052, 2014 Edition, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • BS 7252-4, Withdrawn and replaced by BS ISO 5832-4, Metallic materials for surgical implants. Specification for cobalt-chromium-molybdenum casting alloy
  • BS 7252-11, Withdrawn and replaced by BS ISO 5832-11, Metallic materials for surgical implants. Specification for wrought titanium 6-aluminium 7-niobium alloy
  • BS ISO 5832-4, 2014 Edition, Implants for surgery. Metallic materials. Cobalt-chromium-molybdenum casting alloy
  • BS ISO 5832-11, 2014 Edition, Implants for surgery. Metallic materials. Wrought titanium 6-aluminium 7-niobium alloy
  • BS ISO 5841-2, 2014 Edition, Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads
  • ISO 5832-4, 3rd Edition, Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
  • ISO 5832-11, 2nd Edition, Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
  • ISO 5841-2, 3rd Edition, Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
  • ISO 12891-2, 2nd Edition, Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved surgical implants
  • ISO 14708-1, 2nd Edition, Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer



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